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Monday, 15 November 2010
Page: 1195


Senator McLUCAS (Parliamentary Secretary for Disabilities and Carers) (5:12 PM) —I table revised explanatory memoranda relating to the Australian National Preventive Health Agency Bill 2010 and the Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010 and move:

That these bills be now read a second time.

I seek leave to have the second reading speeches incorporated in Hansard.

Leave granted.

The speeches read as follows—

Australian Civilian Corps Bill 2010

When a country experiences a natural disaster or conflict, the capacity of its government to provide security and basic services for its citizens is often limited.

Hard-won development gains can be undermined and poverty exacerbated.

More needs to be done in the aftermath of natural disasters and conflict to assist stabilisation, recovery and development efforts.

Australia has responded to this need by putting in place a new capability to assist countries affected by crises.

The Australian Civilian Corps is a select group of civilian specialists who deploy to countries experiencing or emerging from natural disaster or conflict.

The Corps supports stabilisation, recovery and development planning.

It will assist crisis-affected countries to restore essential services and strengthen their government institutions.

One such example would be the deployment of an Australian water and sanitation planner to assist local government officials rebuild water infrastructure following a natural disaster.

Another example would be the deployment of an Australian senior government official with expertise in budget administration to assist a country with budget control following a conflict.

The work of the Corps will build on initial emergency humanitarian relief efforts, and help set the foundation for long-term sustainable development.

Between now and 2015 Australia will double its official development assistance and continue to work alongside the international community to help reach the Millennium Development Goals.

The Australian Civilian Corps is just one important new capability in the Australian Government’s development assistance program which is improving the lives of millions of people in developing countries.

The Government announced the initiative at the East Asia Summit in Thailand on 25 October 2009 against the backdrop of multiple disasters in Samoa, Tonga, Indonesia, Vietnam and the Philippines and the ongoing challenges and insecurity in Afghanistan.

This bill provides for the establishment and management of the Australian Civilian Corps.

Members of the Corps will be drawn from a register of civilian specialists selected for their technical skills and ability to work in challenging environments overseas.

They will have expertise in areas such as public administration and finance, law and justice, engineering, agriculture and health administration.

They will be sought from all levels of government and the broader Australian community.

A number of civilian specialists have already been selected, screened and trained for inclusion on the Australian Civilian Corps register, which will be built up progressively to 500 by 2014.

The Bill provides for these civilian specialists to be engaged as a new category of Commonwealth employee in order to deploy with the Corps.

Members of the Australian Civilian Corps will be a unique category of Commonwealth employee, engaged to work in crisis environments overseas for specific periods before returning to their regular employment.

As Commonwealth employees, these individuals will represent the Australian Government in highly challenging environments overseas.

They will have all of the rights and protections afforded to Commonwealth employees, and be covered by the same minimum standards of employment as other Australian employees under the Fair Work Act.

The central purpose of the Bill is to create a legal framework for the effective and fair employment and management of Australian Civilian Corps employees.

The Bill provides for terms and conditions and other employment arrangements that are specifically designed for this unique kind of employment.

AusAID will administer the Australian Civilian Corps, in cooperation with other Australian Government agencies.

The Director General of AusAID, who manages the vast majority of Australia’s international development assistance program, will be responsible for managing the Australian Civilian Corps.

The Bill gives the Director General of AusAID the power to engage Australian Civilian Corps employees and determine their remuneration and other terms and conditions.

These terms and conditions will be tailored to the particular requirements of Australian Civilian Corps employment.

The Australian Civilian Corps will have a set of values prescribed by regulation, which will define the principles, standards and ethics to be embodied by the Corps.

The Director General of AusAID will be required to uphold and promote the Values.

A code of conduct for the Australian Civilian Corps will also be prescribed by regulation, setting out the standards of behaviour and conduct expected of Australian Civilian Corps employees.

The Bill provides for sanctions to be imposed in the event that an Australian Civilian Corps employee breaches the Code.

The Bill also facilitates the transition of civilian specialists between Australian Civilian Corps employment and their regular employment.

The Prime Minister is given a power under the Bill to issue directions to Commonwealth employers about the participation of their employees in the Corps.

The Bill also includes a provision to ensure that all employers can grant leave without pay to their employees for the purpose of undertaking Australian Civilian Corps service.

The Australian Civilian Corps will have the flexibility to deploy in a stand-alone capacity or alongside international partners or other Australian operations including military and police.

The Corps will work closely with bodies such as the United Nations, and the Bill provides for secondments of members of the Corps to such bodies.

The Bill also deals with various other employment arrangements including assignment of duties, suspension and termination from employment.

The Australian Civilian Corps is a valuable new capability that will enhance Australia’s ability to meet requests for assistance following natural disasters and conflict.

The Corps will work in partnership with crisis-affected countries in our region and beyond to assist with stabilisation, recovery and development efforts.

It will build on Australia’s proud history of providing assistance in times of crisis and affirm our status as a good international citizen.

For this initiative to be successful it is essential that a framework exists for the effective and fair employment and management of Australian Civilian Corps employees.

This Bill puts such a framework in place.

I commend the Bill.


Australian National Preventive Health Agency Bill 2010

The Australian National Preventive Health Agency Bill 2010 seeks to focus and revitalise Australia’s preventive health capacity.

It was over a year ago that I first introduced this Bill.

The Government’s intention was for the first Australian National Preventive Health Agency to have been established in January this year.

The Bill now provides a start date as proclaimed by the Governor General once it receives Royal Assent.

The Bill also now proposes:

  • that the Australian National Preventative Health Agency’s strategic plans cover a 5 year rather than a 3 year period, and
  • Explicitly mentions alcohol, tobacco and other substance abuse, and obesity programs as being included in the scope of social marketing campaigns to be undertaken by the Agency.

These amendments were moved by the Greens and Senator Xenophon when the Bill was previously debated in the Senate and the Government has agreed to support them.

This is an important measure that was recommended by both the National Health and Hospitals Reform Commission, and the National Preventative Health Taskforce.

In fact, the creation of a national preventive health agency was also proposed at the 2020 summit in 2008.

In 2008 the Government reached agreement with the states and territories at COAG to create the Agency and committed to funding it with an investment of over $130 million for its establishment, preventative health research and social marketing campaigns.

The Government has listened and we are now acting because we know that preventative health measures work.

We understand that the rising incidence of chronic illness, combined with an ageing population, mean that sitting on our hands is not an option in terms of both the cost to our health and hospital system, and more importantly in terms of the human cost of illness and lost productivity.

This Bill establishes national infrastructure to help drive major change in the way we behave and how we look after (or don’t look after) our own health.

It is widely appreciated that population growth and an ageing population is one of the major challenges to our health and hospital system.

But there are also major pressures arising from our changing lifestyles and consumption patterns.

The Government knows that prevention is better than cure and is why we have already taken strong action across a range of areas.

We know that between 1950 and 2008, more than 900,000 Australians died because they smoked - despite the fact that there was from about 1950 clear evidence on the dangers of smoking.

That’s why successive governments have taken action - including increasing the excise applying to tobacco products, conducting hard-hitting social marketing campaigns, banning tobacco advertising and introducing graphic warning labels.

Thanks to these and other preventive health measures we now have one of the lowest smoking levels in the world.

However there are still nearly three million Australians who continue to smoke.

Tobacco remains the single-biggest preventable cause of death and disease in Australia.

That’s why the Government has committed to world leading reforms to stop smoking - including

  • increasing the tobacco excise by 25 per cent from April this year,
  • investing an additional $5 million in Quitline services,
  • investing $85 million in anti tobacco campaigns and
  • being the first country in the world to introduce plain packaging of tobacco products - ending the last avenue for cigarette companies to advertise.

A key job of the new Australian National Preventive Health Agency established by the Bill will be to build upon these reforms to ensure that we reduce this burden.

Similarly, with alcohol, Australians all around the country know the severe impact of alcohol abuse in our community.

In contrast to tobacco, our overall per capita consumption of alcohol is high by world standards.

One in four Australians drink at a level that puts them at risk of short-term harm at least once a month.

Around 10 per cent of Australians drink at levels that put them at risk of long term harm.

The Government has already taken action, including by:

  • Launching the $103 million National Binge Drinking Campaign; and
  • Ending the tax loophole on alcopops that target young people. This measure has seen their consumption drop by 30 per cent

But there is more work to be done, which the Preventative Health Agency will be the Government’s leading advisers on.

And on top of that, we are now among the most obese nations in the world.

The National Preventative Health Taskforce stated that if obesity trends are left unchecked, the life expectancy for Australian children alive today will fall two years by the time they are 20 years old.

We’ve understood this through our investments in the National Partnership Agreement on Preventative Health which will invest $872 million for prevention, in particular with a large emphasis on tackling obesity - through workplaces, local governments and programs targeted at children.

These examples illustrate why the Government has made prevention a key focus of our reform agenda.

We must ensure that Australia does not go backwards in health status.

And we have to make our health and hospital system sustainable in the long term.

We need to reduce the burden preventable health problems are already placing on an ageing workforce, and ensure Australia’s productive capacity is maintained.

In the past the prevention effort has been neglected. We know that arrangements have been fragmented and lacked cohesion and focus.

Success in changing lifestyles takes a long term, systematic approach informed by the latest evidence and ongoing evaluation of results.

It needs engagement, action and responsibility to be taken by individuals, families, communities, industries and businesses.

But Government, can play a leadership role by gathering and analysing and disseminating the best available evidence, and implementing programs and policies based on the evidence.

We need to bring together the best expertise in the country, and we need to engage employers, businesses and the wider community in prevention.

A new approach is needed, and the new Australian National Preventive Health Agency will play a key role in achieving this ambition through the deployment of a skilled and dedicated team which can work flexibly and responsively.

The Agency will also be an important part of our overall health reform efforts, and will work with Medicare Locals to reinvigorate preventative health efforts at the local level.

There is also opportunity for the Agency to strategically assess the social determinants of health as shown earlier this week by a report commissioned by Catholic Health Australia, Health Lies in Wealth.

The report shows that 65 per cent of those in the lowest income group report a long-term health problem compared with just 15 per cent of the most wealthy.

The establishment of the Australian National Preventive Health Agency will embed preventative health thinking and action, permanently, into the future as an enduring institution.

The staff will include population health and other experts. It will have responsibility for providing evidence-based policy advice to health and other ministers and will administer social marketing programs and other national preventive health programs which it may be tasked with by Australian Health Ministers.

It will also form partnerships with industry, as well as the community and non-government sectors.

$17.6 million has been allocated for the establishment and operation of the Agency, together with funding for social marketing targeting obesity and tobacco ($102 million) and to support preventive health research, especially the translation of research into practice ($13.1 million).

This Bill establishes the Agency as a statutory authority under the Financial Management and Accountability Act 1997, or FMA Act, and specifies its functions, governance and structure.

Health Ministers have agreed to the Agency being established under the FMA Act and were consulted about the broad provisions in the Bill.

A Chief Executive Officer will manage the Australian National Preventive Health Agency and will be directly accountable to the Federal Health Minister for the financial management of the Agency and to the Australian Health Minister’s Conference, via the Minister for Health and Ageing, for the Agency’s performance.

There will be an Advisory Council which will consist of experts in the field of preventative health.

Preventive health is a policy area which the Government has given the highest priority.

That is why I have introduced the Bill this sitting to allow the Agency to commence its important work as soon as possible.

Once established it will mean that for the first time, Australia will have a dedicated organisation to help us combat the complex challenges of preventable chronic disease.

It will benefit all Australians, now and into the future, and will play a significant role in putting Australia on the path to becoming a healthier country.


Radiocommunications Amendment Bill 2010

The Bill proposes amendments to the Radiocommunications Act 1992 (the Act) to:

  • give the independent radiocommunications regulator, the Australian Communications and Media Authority (ACMA for short), greater flexibility in the timeframe in which it can commence reissuing spectrum licences;
  • allow the ACMA to issue class licences in the same spectrum space allocated or designated for spectrum licences (coexistence);
  • vary the treatment of certain Ministerial determinations and directions made under the Act; and
  • provide additional clarity for Ministerial directions to the ACMA relating to spectrum access charges.

In the late 1990s, the Government commenced auctioning a number of spectrum licences to support a market based approach to the licensing of radiofrequency spectrum.  

The licences had a 15-year tenure, flexible conditions and were fully tradeable.   Australia was amongst the first countries in the world to issue licences on this basis.  

Many of these licences are now used by telecommunication carriers to provide mobile phone and wireless access services to millions of Australians.

The first of the 15-year licences are due to expire in 2013 with the remainder by 2017.

Currently the Act requires the ACMA to publish a notice advising which spectrum licences are due to expire within the next two years, and inviting expressions of interest in the spectrum, but prevents it from doing this earlier.

The ACMA is also restricted from issuing draft spectrum licences as part of their marketing plan until two years prior to the licences’ expiry.

Incumbent licensees have consistently called for greater certainty about licence reissue.  

Without such certainty it is claimed that there will be a reluctance to maintain investment in infrastructure and service provision with potential adverse impacts on coverage and service quality.

The Bill amends the Act to remove the current timing constraint which restricts the ACMA to publishing notices about expiring spectrum licences and publishing draft spectrum licences to two years prior to licence expiry.  

Removing this time constraint will provide greater flexibility for the ACMA in terms of when it can commence licence reissue processes, and allows the industry greater certainty which it is calling for.

The ACMA would still be required to seek expressions of interest for spectrum licences prior to expiry.

The Bill also amends the Act to permit coexistence of class licences and spectrum licences in the same spectrum band.

New technologies are being developed that could greatly increase the technical and productive efficiency of spectrum use, and allow devices to share spectrum with traditional radiocommunciations without harmful interference.  

Over time there will be widespread adoption of new technologies in a range of devices that would be readily available in Australia.  

These new technologies may be authorised for use in Australia by the ACMA under class licences.

Under current legislation, in bands subject to spectrum licensing, the only way to accommodate these new technologies is through a third-party authorisation by the incumbent spectrum licensee.   To date, experience has shown this to be problematic.

It is important that the Australian radiocommunications regulatory framework is sufficiently flexible to deal with new technology challenges and to enhance the effective management and allocation of spectrum.

The Bill makes additional amendments to clarify the operation of provisions relating to the variation of existing class licences to coexist with spectrum licences in the same spectrum allocation.

The Bill includes adequate safeguards.  

Before applying any coexistence provisions involving class licences in a spectrum licensed allocation, the ACMA would be required to develop adequate safeguards through consultation with industry.  

The ACMA would also need to satisfy itself that the new technologies coexist without unacceptable interference to primary services and are in the public interest.

The amendments on coexistence will not affect current spectrum licences and licensees. The new arrangement will only impact future new or reissued spectrum licences issued after the amendments come into effect.

The Bill amends the Act to make ministerial determinations, which specify classes of services for which reissuing the same licence to the same licensee is in the public interest, legislative instruments that are not subject to disallowance.  

These determinations will, however, be published on the Federal Register of Legislative Instruments.

These changes are proposed in order to minimise unnecessary delays in the re-issuance process.   Delays from the possible disallowance of a determination could have a material negative impact on conducting licence reissue discussions with incumbent licensees, particularly those licences which are due to expire in mid 2013.  

The Bill further amends the Act so ministerial directions to the ACMA concerning spectrum access charges are not legislative instruments.  

The measure is consistent with existing provisions in the Legislative Instruments Act 2003 that instruments of this kind are not legislative in nature.  

The amendment will also protect commercially sensitive pricing information relating to the licence reissue discussions from being published before ACMA reissue processes are completed.  

Consistent with current practices, it is expected the ACMA would make known the prices paid for reissued licences once the reissuance process is complete.  

Finally, the Bill makes a minor amendment - for the avoidance of doubt - that a ministerial spectrum access direction may require the charge to reflect the amount that the Minister considers to be the value of the spectrum.

It is intended that such a direction in relation to spectrum licence reissue would only take place once the Minister has taken into account the public interest.


Social Security Legislation Amendment (Connecting People with Jobs) Bill 2010

This Government has done everything within its power to tackle unemployment during a difficult economic time.

We took quick and decisive action when the Global Financial Crisis hit.

While 16 million jobs have been lost in other advanced economies, Australia has created more than 300,000 jobs since the Global Financial Crisis began almost two years ago.

Through our Nation Building Infrastructure Program we are building the infrastructure we need for the future, while creating the jobs Australians need today.  

And we have strengthened Australia’s employment services with the creation of Jobs Services Australia and Disability Employment Services, in order to provide unemployed Australians with the opportunity to train and the opportunity to work.

Our policies are working. Unemployment is 5.4 per cent, almost half that of the United States.

Since Jobs Services Australia has been operating, I am proud that more than 400,000 Australians have been placed into jobs. Of these 33 per cent were jobs for the most disadvantaged job seekers.

We have also uncapped employment services for the first time for people with disability.

We have also worked to ensure that the job seeker compliance system is effective to keep job seekers engaged.

The Connecting People with Jobs package will build further on these commitments to improve labour mobility and improve supports for long term unemployed job seekers as well as strengthen associated compliance measures.

The Connecting People with Jobs package will commence on 1 January 2011 and provide support for long term unemployed job seekers living in areas with high unemployment rates to move take up a full-time job or apprenticeship.

Job seekers will be eligible for reimbursement of up to $3000 for relocating to a metropolitan area, or $6000 for moving to fill a job in a regional area. They may be eligible for an additional $3000 if they are relocating with their family.

Relocation often has high costs, especially when it involves moving interstate or even across the country. These job seekers have sought employment in their current location for at least 12 months, but may lack the resources to move to take up employment further afield. That’s why in August the Prime Minister announced the relocation trial as part of ‘Modernising of Australia’s Welfare System’, helping the long-term unemployed overcome costs to take up meaningful work in a new location. 

As part of Labor’s election commitment, employers will also be eligible for a wage subsidy of $2,500 to create an upfront incentive for taking on these job seekers. This is in recognition of the additional support and assistance individuals will need in the early stages of their employment in a new location.

Job seeker compliance

While this package will encourage the long term unemployed to relocate to take up a job, it will also create an incentive for individuals to stay in their new location, and keep them in sustainable employment.

This bill, the Social Security Amendment (Connecting People with Jobs) Bill 2010 amends the Social Security (Administration) Act 1999 to extend to 12 weeks the period of non-payment of income support should a relocating job seeker, who receives additional assistance under this measure from Government, leave their job within the first six months as a result of a voluntary act or misconduct.

Previously a job seeker was subject to an 8 week non-payment period.

This bill does not alter existing mechanisms for exemption for such non-payment period penalties that are administered by Centrelink.  

Need for a flexible labour market

The national unemployment rate currently sits at 5.4 per cent, down from 5.7 per cent a year ago, however the truth is that the employment situation across Australia varies greatly.

In this modern age, there is a need for greater labour mobility, and relocating parts of the workforce to meet employers’ demand is an effective method of achieving this. The Connecting People with Jobs trial will enhance the flexibility of the labour market by encouraging additional relocation activity, and helping to better match labour supply with demand.

The funds for relocation will provide job seekers with assistance for things such as:

  • Airfares
  • Removalists
  • Temporary accommodation
  • Post-placement support and mentoring

This trial will get people off income support and into sustainable jobs.

Conclusion

We know long-term unemployed people are particularly vulnerable in the current economic environment.

We know there are businesses and industries out there experiencing labour shortages in parts of the country.

We know some of our long-term unemployed live in areas with very limited job prospects.

This legislation will assist the long-term unemployed find sustainable work.

It will provide employers with the workers they need to grow their businesses.


Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010

This Bill makes amendments to improve the regulation of therapeutic goods in Australia under the Therapeutic Goods Act 1989 and to formalise a number of administrative arrangements currently part of that regulation.

The Government is committed to maintaining the position of the Therapeutic Goods Administration as a leading global regulator of therapeutic goods.

This means that the legislation under which the TGA works needs to be updated to meet emerging issues and ensure that the Act gives the regulator the necessary powers to exercise its functions fairly and effectively.

This is the fifth in a series of amendment Bills since 2008 to make much needed improvements to the Act. As a Government we have now disposed of the backlog of amendments to the Act that had been stockpiled in the lead-up to the introduction of the now postponed joint regulatory agency with New Zealand.

Schedule 1 of this bill will introduce measures allowing for the short term exemption from registration of medical devices to serve as substitutes for devices that are included in the Australian Register of Therapeutic Goods but are unavailable or in short supply, and medical devices that have no substitute in the Register. These provisions mirror those already included in the Act in relation to medicines. They are mainly used to deal with disruptions to the availability in Australia of medicines caused by supply chain problems, such as refurbishment of manufacturing facilities.

While the unavailability of medical devices has not been a major problem, the Government believes that including a similar provision in the Act will allow appropriate flexibility in the medical device regulatory framework.

Under the proposed amendments the Secretary of the Department of Health and Ageing may grant a person approval to import, or import and supply, a medical device as a substitute for a device already registered in Australia if the device is marketed in a country specified in the regulations or if an application has been made to register the device in Australia, and the Secretary considers the approval is in the interests of public health.

If the application is to import, or import and supply, a device where there is no substitute already registered in Australia, the Secretary may grant the approval only if an application has been made to register the device in Australia, and the Secretary considers the approval is in the interests of public health.

These provisions do not take away the ability of a doctor to supply an unapproved medical device in an emergency situation that already exists under the Act. Rather, they operate to deal in a systematic way with the unavailability of approved medical devices. Other amendments allow the Secretary to gather information on the supply and use of devices covered by an approval, and allow for the recall of the devices under certain circumstances. The Schedule also contains consequential amendments to the offence provisions in the Act relevant to medical devices.

Schedule 1A of the Bill formalises the current processes that apply to the approval of product information documents of high risk medicines such as prescription medicines.

A product information document contains technical information about the medicine such as the characteristic of the active ingredient, its indications and contraindications, precautions, adverse reactions that may occur from the use of the medicine, dosages, and other information relating to the safe and effective use of the medicine. This document assists medical practitioners, pharmacists and other healthcare professionals in prescribing, dispensing and administering the medicine, and in educating patients on its safe and effective use.

Applications for inclusion of prescription medicines in the Register under the Act are required to include a draft product information document that is approved on registration of the medicine. It is also a condition of registration of these medicines that the product information approved by the Secretary at the time of registration can only be varied with the Secretary’s approval.

The amendments under Schedule 1A formalises these requirements. The Minister will have the power to make legislative instruments that specify a medicine or medicines to which the requirements relating to product information documents apply. A draft product information document must be lodged in a form approved by the Secretary with the application for such medicines. Approval of the product information document at the time of registration of the medicine and any approval relating to its variation will be notified to the sponsor of the medicine.

Schedule 2 of the Bill includes a range of amendments to various provisions in the Act.

One of the more significant amendments will include an explicit pathway for sponsors of medicines already included in the Register to list an export-only variant of the medicine. Although the Act currently allows medicines to be listed for export, there is no link between these medicines and a medicine already on the Register.

The new provision will allow the Secretary to list a variation of an existing medicine on the Register so long as the variant differs from the medicine in the Register only in respect of characteristics (such as colourings, flavourings and excipients) that are specified in a legislative instrument made by the Minister.

This provision will support Australian companies wishing to export medicines by allowing them to state to authorities in the importing country that the medicines are a minor variation of a medicine available on the Australian domestic market, and point to the provision in the Act that allows the listing of such variants.

Amendments applying to the variation of entries of therapeutic goods in the Register under section 9D of the Act are also included in Schedule 2. Some of these amendments are a consequence of the changes relating to product information described previously and others allow for variation of information in the entry in the Register concerning medical devices and biological in the same way as is currently allowed for the variation of information in relation to medicines.

These amendments also address the possible argument that a request for a variation to an entry of a medicine that has the effect of reducing the class of patients for whom the medicine is suitable could result in the medicine becoming a “separate and distinct” therapeutic good under section 16 of the Act and therefore requiring a new application for registration to be made. As the Secretary is required under section 9D to vary an entry where such a “safety-related” request is made (on the basis that no new evaluation of the safety, quality or efficacy of the medicine is necessary), these amendments clarify that section 16 cannot apply.

Schedule 2 also contains amendments that clarify the Secretary’s power to make determinations that goods are “therapeutic goods”. Section 7 of the Act enables the Secretary to declare particular goods are therapeutic goods or are not therapeutic goods, including when used, advertised, or presented for supply in particular way.

For this declaration to be made, the Secretary must be satisfied that the goods are or are not in fact therapeutic goods. The current definition of therapeutic goods under the Act excludes goods that fall within a food standard made under the Food Standards Australia New Zealand Act 1991 and goods that have a tradition of use as food for humans in either Australia or New Zealand in the form in which they are presented, unless there is a section 7 declaration that they are therapeutic goods. There are a number of products in relation to which therapeutic claims are made but as they fall within a food standard the Secretary is currently unable to make a section 7 declaration.

These amendments will allow the Secretary to make a declaration that certain goods are therapeutic goods if the only reason that they are not therapeutic goods is because of the existence of the food standard or because they have a tradition of use as food for humans as defined in the Act. This provides flexibility and allows for such goods to be regulated as therapeutic goods in appropriate cases.

The Therapeutic Goods Administration has been working with industry to identify ways in which to improve the regulatory business process in relation to the registration of prescription medicines. The recent review process which commenced in December 2007 has had the extensive involvement of relevant stakeholders. This review identified a number of areas where the registration process could be improved. The changes now being implemented are designed to reduce the current 500 days for a new prescription medicine to be registered to approximately 300 days by eliminating unnecessary queues and delays in the evaluation process.

These amendments include changes to support elements of this business process reform. They will allow the evaluation and decision-making process to proceed even though the applicant may not have provided all the information or documents about the application that have been requested by the Secretary within the agreed timeframes, changes to clarify how those timeframes are determined and for the Secretary to approve the form of requests for the variation of entries of medicines already in the Register.

Another group of amendments in the Schedule improve the TGA’s ability to obtain information from the sponsors of registered or listed medicines.

The Act already includes powers for the Secretary to request information and documents on a wide range of matters relevant to registered and listed medicines. However, while the Secretary can impose conditions on the registration or listing of medicines, there is no explicit power for the Secretary to obtain information and documents relating to compliance with these conditions. The amendments include such a power.

The amendments also add a power for the Secretary to obtain information or documents on whether registered or listed medicines have been imported into or supplied in Australia, or exported from Australia. This information can be very important in assessing the risk arising from an identified deficiency with a medicine and some sponsors have in the past refused to provide it. These amendments put beyond doubt the Secretary’s power to obtain the information.

The Schedule also amends the provisions relating to reconsideration by the Minister of initial decisions by the Secretary and delegates in the TGA. Under the current provisions persons affected by an initial decision can request reconsideration by the Minister within 90 days of the decision. The Minister is required to reach a decision within 60 days after the request was made.

It is not uncommon for persons to apply for reconsideration but not supply any supporting information until well into the 60 day period. There is currently nothing in the Act to prevent the applicant providing additional information on 59th day.

The amendments to section 60 address this by requiring persons requesting reconsideration of a decision to submit any information they wish the Minister to consider at the time of application for the review. The amendments then preclude the Minister from considering any further information provided by the person unless it is information provided in response to a request by the Minister or is information indicating the quality, safety or efficacy of the therapeutic goods involved is unacceptable.

These amendments will ensure that reconsideration by the Minister is based on a deliberate analysis of all the relevant information, and avoid the need for hasty review of what might be complex information supplied when the review is already underway.

The Schedule also amends the provisions allowing the Minister to determine lists of permitted ingredients to be included in medicines. These amendments are essentially technical changes to improve the workability of the provisions by allowing the list of permitted ingredients to include ingredients meeting specific requirements and setting out the criteria (of safety and quality) that the Minister must apply in deciding whether to vary a determination of permitted ingredients in response to an application.

Finally, the Schedule clarifies that any fee payable for an audit of a medical device must be paid before the inclusion of the device in the Register. This will ensure that all applicants pay the appropriate fee.

Together with the earlier regulatory reforms introduced by the Government, this Bill ensures that the TGA can continue to operate effectively as one of the leading therapeutic goods regulators in the world.

Debate (on motion by Senator McLucas) adjourned.

Ordered that the bills be listed on the Notice Paper as separate orders of the day.